FDA Drug recall D-1185-2018
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,…
- FDA Drug
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,… by Par Pharmaceutical, citing failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1185-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-06 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
Product
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Reason
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Identifiers
| code_info | Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1185-2018%22
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